CompletedNot Applicable

Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer

United States25 participantsStarted 1999-01

Plain-language summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of a high-risk indolent hematologic malignancy meeting the following criteria: * Chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria: * In second or subsequent remission * Failed to achieve a complete remission (CR) after chemotherapy * Non-Hodgkin's lymphoma (NHL) meeting 1 of the following criteria: * Low-grade NHL meeting 1 of the following criteria: * Standard-risk disease in second or subsequent remission * Standard-risk disease and failed to achieve a CR after chemotherapy * In first or subsequent remission with adverse International Prognostic Index (IPI) prognostic features, as defined by the presence of ≥ 3 of the following: * Age \> 60 years * Tumor stage III or IV * Extranodal disease at \> 1 site * ECOG performance status ≥ 2 * Serum lactic dehydrogenase (LDH) \> upper limit of normal (ULN) * Intermediate- or high-grade NHL meeting 1 of the following criteria: * In second or subsequent remission * Failed to achieve a CR after initial chemotherapy * Waldenstrom's macroglobulinemia meeting 1 of the following criteria: * In second or subsequent remission * Failed to achieve a CR after initial chemotherapy * Multiple myeloma meeting 1 of the following criteria: * In first or subsequent remission * Failed to achieve a CR after initial chemotherapy * Myeloproliferative disorders, including any of…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Toxicity and survival

Timeframe: up to 36 months post transplant

Trial details

NCT IDNCT00296023

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-06

View on ClinicalTrials.gov More Chronic Myeloproliferative Disorders trials